Effectiveness comparison of online and telephone counseling on rational-emotional-behavioral therapy on sexual function of women undergoing cardiac rehabilitation
Effectiveness comparison of online and telephone counseling on rational-emotional-behavioral therapy on sexual function of women undergoing cardiac rehabilitation
Design
Clinical trial with online intervention group and control of rational-emotional-behavioral telephone intervention with parallel, randomized groups on 48 patients. Random allocation online site was used for randomization. Http://www.randomization.com
Settings and conduct
Research environment of Afsharizd Hospital Using the online site of random allocation of women, they were divided into two groups of telephone intervention and online intervention control. Both groups receive eight 30- to 90-minute individual counseling sessions with the same content. Data collection tools at the beginning of the study are demographic questions. At the beginning of the study, the women's sexual function questionnaire is completed at the end of weeks 8 and 12 of the study. Data are analyzed by descriptive and inferential statistical tests.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women undergoing cardiac rehabilitation, Iranian ethnicity, literacy, internet literacy, having a file in the heart center of Afshar Hospital, heart disease and confirmation that sex is permissible for them, willingness to participate in the study , Do homework
Intervention groups
They are divided into two groups: telephone intervention and online control of intellectual-emotional-behavioral intervention.
Main outcome variables
1. Women's sexual function
2- Satisfaction with the counseling method
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201222049797N1
Registration date:2021-02-07, 1399/11/19
Registration timing:prospective
Last update:2021-02-07, 1399/11/19
Update count:0
Registration date
2021-02-07, 1399/11/19
Registrant information
Name
fatemeh zahra memar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5227 4486
Email address
memar_fateme@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness comparison of online and telephone counseling on rational-emotional-behavioral therapy on sexual function of women undergoing cardiac rehabilitation
Public title
Effectiveness comparison of online and telephone counseling on rational-emotional-behavioral therapy on sexual function of women undergoing cardiac rehabilitation
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women undergoing cardiac rehabilitation
Iranian
ethnicity Literacy and literacy for both online and telephone counseling groups
Internet and smart phone literacy for both groups
Having a file at the heart center of Afshar Hospital
Having heart disease approved by a cardiologist Sex is permissible for them
They are being treated at the heart center of Afshar Hospital.
Having the desire and interest to participate in the study
is an agreement to do the relevant homework
Exclusion criteria:
Pregnancy
Simultaneously participate in another study
a history of other chronic mental and physical illnesses self-reported
use of drugs other than drugs related to heart disease self-reported
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size includes 48 women. Each woman can be assigned a number between 1 and 48, which can be done by referring to the online site of random allocation. Currently, there are three models of random allocation, and considering that this model is in two groups, the first generation randomization model can be used. Each sample is placed in a treatment group and is done through the site.http://www.randomization.com Through the blocks that are on the site, groups A and B are entered in the treatment groups section, and then the number of samples, which is 48, is entered in the number of people in the treatment blocks, where the software of each sample They are randomly assigned to one of the two groups A and B, which means that the allocation of samples to each of the two groups does not occur in A and B, respectively, but in the order in which the software output is placed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Murad Maleki.no 99
City
Zarrinshahr
Province
Isfehan
Postal code
8471846596
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.SSU.REC.1399.205
Health conditions studied
1
Description of health condition studied
Sexual function of patients undergoing cardiac rehabilitation
ICD-10 code
I24
ICD-10 code description
Other acute ischemic heart diseases
Primary outcomes
1
Description
Change in the mean scores of sexual function, which is measured with the Mohammadi Women's Sexual Function Questionnaire
Timepoint
The female sexual function questionnaire is completed at the beginning of the baseline study, at the end of week 8 of the intervention and at week 12 at the end of the study.
Method of measurement
Women's sexual function, which is based on the questionnaire of Iranian species Mohammadi et al., Which measures women's sexual function in 6 areas, indicates a higher score of better sexual function.
Secondary outcomes
1
Description
Satisfaction with the counseling method is measured on a ten-part scale with a researcher-made questionnaire
Timepoint
At the end of week 8 and the end of week 12, the intervention of the intervention method is measured by a researcher-made questionnaire.
Method of measurement
Satisfaction with the consulting approach with a researcher-made questionnaire using related references (Cronbach's alpha 0.87) with four questions and a ten-part scoring scale with a minimum score of 4 and a maximum of 40
Intervention groups
1
Description
Intervention group: Intellectual-emotional-behavioral telephone counseling with 8 sessions of 30-90 minute individual counseling with the content of intellectual-emotional-behavioral counseling sessions once a week, according to the plan between the researcher and the client by the researcher after prior coordination with the women in this group. It is done individually by phone for 8 weeks. The cost of the phone call will be charged to the women's SIM cards until the end of the study
Category
Treatment - Other
2
Description
Control group:Online rational-emotional-behavioral counseling that received 8 sessions of 30-90 minute individual counseling with the content of intellectual-emotional-behavioral counseling sessions, through WhatsApp software and Skyroom software equipped with private space security in the form of multimedia and chat The internet package is given to women free of charge in the online counseling group on a weekly basis until the end of the study period
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart Center of Mohammad Sadegh Afshar Hospital, Yazd
Full name of responsible person
Dr. Khalil Forouzannia
Street address
Jomhory St. - Mohammad Sadegh Afshar Hospital
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 5011
Email
afsharhospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
5 km of Bafgh Old Road - International Branch of Shahid Sadoughi University of Medical Sciences and Health Services, Yazd
City
Yazd
Province
Yazd
Postal code
8944158318
Phone
+98 35 3836 7634
Email
international@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Tahmineh Faraj Khoda
Position
PhD in Reproductive Health Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Yazd - Safaieh - Timsar Fallahi St. - Bouali Alley School of Midwifery Nursing
City
Yazd
Province
Yazd
Postal code
8916878397
Phone
+98 35 3824 1751
Email
farajkhoda_t@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Tahmineh Faraj Khoda
Position
PhD in Reproductive Health Associate Professor Shahid Sadoughi University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Safaieh - Timsar Fallahi St. - Bouali Alley, School of Midwifery Nursing
City
Yazd
Province
Yazd
Postal code
8916878397
Phone
+98 35 3824 1751
Email
farajkhoda_t@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Tahmineh Faraj Khoda
Position
PhD in Reproductive Health Associate Professor Shahid Sadoughi University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Safaieh - Timsar Fallahi St. - Bouali Alley, School of Midwifery Nursing
City
Yazd
Province
Yazd
Postal code
8916878397
Phone
+98 35 3824 1751
Email
farajkhoda_t@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available